FDA Medical Device Recalls (openFDA)
Exactech, Inc.: 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.
- Recall number
- Z-0361-2020
- Recalling firm
- Exactech, Inc.
- Product
- 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.
- Status
- Terminated
- Initiated
- 2019-10-02
- Posted
- not on file
- Terminated
- 2023-05-19
- Reason
- Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
- Root cause
- Error in labeling
- Action
- Exactech notified customers on about 10/02/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that the 2.4mm x 2.5" Fluted Pin Pouch was found to contain a single pin rather than four (4) as labeled. Instructions included to immediately cease distribution or use of the affected product, provide the information to customers if further distributed, identify and quarantine any of the affected devices in inventory, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email to recalls@exac.com.
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of GA, NY, OH, VA.
- Lot, serial or model codes
- Catalog Number: 351-90-22; UDI Number: 10885862567529; Expiration Date: 08/28/2028; Serial Numbers (6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, 6189273); Packaging Lots Numbers (49079322, 49079321); Manufacturing Lot Number:19030412
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDL
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28